BEUDAMED
    MDR MDR QMS Issued

    HZ 1396541-1

    Manufacturer: Orbisana Healthcare GmbH
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Rev. 0

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    1155
    Valid for 1155 days
    Expiry: September 24, 2029

    Basic Information

    Number
    HZ 1396541-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    September 25, 2024
    Expiry Date
    September 24, 2029
    Revision
    Rev. 0
    Manufacturer
    Orbisana Healthcare GmbH

    Certificate Lifecycle

    September 25, 2024 September 24, 2029

    Scopes

    Quality Procedure Scope

    Device Group Class IIa

    Y214212 DEVICES FOR COMUNICATION, VOICE GENERATORS

    Basic UDI-DIs

    This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.